Scott Klug: “it gets back to what I was talking about earlier with medical devices. It is part of that culture of fear. It is a fear…”

“it gets back to what I was talking about earlier with medical devices. It is part of that culture of fear. It is a fear within the FDA itself that they cannot say yes. If they say yes, it is that on-in-a-million chance that something will go wrong. But when you look at pharmaceutical products, what you forget is that 999,000 cases where something goes right; and that has really been the problem. Again on the Delaney clause, what you have to remember is this is a very centrist idea. Al Gore suggested it. Dr. Kessler at the head of the Food and Drug Administration, when he was a staffer in the U.S. Senate, spent years trying to fix the Delaney clause. So this is not any radical idea. If you can get Al Gore and David Kessler and Joe Barton and Scott Klug and Jim Greenwood to all agree on the same issues, I would suggest everybody, including everybody at the FDA, understands Delaney does not work and that it has to get fixed.”